Abstract
Clarithromycin is a broad-spectrum semi-synthetic macrolide indicated for treatment of pneumonias, Helicobacter pylori, and chlamydial and skin infections. The object of this study was to evaluate the pharmaceutical equivalence of 14 generic clarithromycin products marketed in Nairobi County, Kenya, to the innovator products, using in vitro dissolution profiles and similarity factors (f2). Further, dissolution profiles of four innovator formulations manufactured in different sites were compared. Fourteen clarithromycin tablets/capsules and four suspensions were subjected to assay and comparative dissolution runs at pH 1.2, 4.5 and 6.8, for 60 and 90 min, respectively. All products complied with pharmacopoeial assay specifications. However, significant differences were observed in their dissolution profiles. The non-compliance rates for tablets/capsules were 50% at pH 1.2, 33% at pH 4.5 and 50% at pH 6.8, while none of the four suspensions were compliant. Overall, only four (25%) products complied with the specifications for similarity factor. The results obtained indicate that a significant percentage of generic clarithromycin products are pharmaceutically non-equivalent to the innovator products, and that assay and single-point dissolution tests are insufficient demonstration of equivalence between the generic and innovator products.
Highlights
Clarithromycin is a broad-spectrum semi-synthetic derivative of erythromycin with activity against a wide range of Gram-positive and Gram-negative bacteria, as well as the atypical microorganisms Mycoplasma pneumoniae, Chlamydia trachomatis, Chlamydophila pneumoniae, Legionella spp., Borrelia spp., Mycobacteria, Ureaplasma, and Toxoplasma
Products in comparison with innovator products by Klacid® (Abbott Laboratories Ltd., Johannesburg, The aim of this study was to evaluate the pharmaceutical equivalence of generic clarithromycin South Africa) through comparison of their dissolution profiles
Study, itit was was noted noted that that aa significant significant percentage percentage of of clarithromycin clarithromycin generics generics did did not not comply specifications of similarity factorfactor with respect to innovator productsproducts despite yielding complywith withthe the specifications of similarity with respect to innovator despite comparable single-point dissolutiondissolution results
Summary
Clarithromycin is a broad-spectrum semi-synthetic derivative of erythromycin with activity against a wide range of Gram-positive and Gram-negative bacteria, as well as the atypical microorganisms Mycoplasma pneumoniae, Chlamydia trachomatis, Chlamydophila pneumoniae, Legionella spp., Borrelia spp., Mycobacteria, Ureaplasma, and Toxoplasma It is indicated in the management of atypical community acquired pneumonia, chlamydial infections, legionella pneumonia, and acute non-specific urethritis, as well as skin infections, disseminated mycobacterial infections, and the eradication of Helicobacter pylori as a component of triple therapy in peptic ulcer disease [1,2,3]. Previous studies have reported that clarithromycin undergoes rapid degradation under conditions of low pH that exist in gastric fluid [6,9]. Given that the gastric and intestinal residence times of clarithromycin are 0.5–2 h and
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